- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the timeline, budget and objectives set forth by the Study team. The Clinical Study Manager role is primarily a tactical study delivery role, reporting ... in accordance with DS standards. Act as the project manager of the clinical study team to...with the CRO to prepare and execute meetings including Vendor kick-off meetings and investigator meetings and training.Note that… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within...other vendor performance against project goals and milestones to monitor… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …learned, as appropriate.- Metrics:-When needed, help support the partnership with Clinical Trial Business Operations (CTBO)to:-monitor GCO processes and ... with minimum of 5 years' experience in pharmaceutical or biotechnology across clinical trial operations. Experience in training, process improvement, and project… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …skills preferred.Excellent time management skills preferred.Experience with PH.1 - PH. IV clinical trial vendor contracts required.Experience with CRO ... Degree preferably in Life Sciences required Experience Qualifications4 or More Years in clinical trial outsourcing, health sciences or related field ( clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders.Summary The purpose of this job is to oversee statistical vendor deliverables, perform programmatic review of analysis datasets and Table, Listing, ... and Figures (TLFs) generated by vendor , ensure deliverable quality, and expedite the preparation of oncology compound regulatory submission. It will also to maintain… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …execution requiredStrong experience in procedural writing and life cycle management requiredAdditional clinical trial process experience in one or more key ... around rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and Life Cycle Management, will be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and suggest innovative approaches to improve compliances and processes.- Some knowledge of clinical trial methodologies. Travel Ability to travel up to 10% ... review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low to… more
- IQVIA (Newark, NJ)
- **Elevate Your Career as a Clinical Trial Vendor Manager !** **About the Role:** Step into a world where your expertise in clinical vendor ... management becomes the catalyst for advancing medical breakthroughs. As a ** Clinical Trial Vendor Manager ** , you'll play a key role in our clinical … more
- Pfizer (New York, NY)
- …range of different countries + Clinical Trial Execution + Clinical Documentation + Vendor Management and Oversight + Experience supporting regulatory ... for 8,000 business users of TMF across Pfizer and vendor partners, including direct support for TMF Study Owners...functions + Coordinate TMF Lock process & activities across clinical trial portfolio + Identify and resolve… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …etc. + Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. + ... Ensures compliance with the clinical trial registry requirements + Identifies outsourcing...collaborations + Applies advanced negotiation and interpersonal skills to vendor management + Advanced technical proficiency in trial… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …etc. + Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. + ... Ensures compliance with the clinical trial registry requirements + Identifies outsourcing...to build productive study teams and collaborations + Demonstrated vendor management experience + Technical proficiency in trial… more
- Bristol Myers Squibb (Madison, NJ)
- …projects * Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects * ... database Lock . **Position Summary / Objective** The Senior Manager , Clinical Data Management is a leadership...multi-disciplinary project teams and develop productive relationships with external vendor s + Sound knowledge of Clinical … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to the timeline, budget and objectives set forth by the Study team. The Clinical Study Manager role is primarily a tactical study delivery role, reporting ... in accordance with DS standards. Act as the project manager of the clinical study team to...with the CRO to prepare and execute meetings including Vendor kick-off meetings and investigator meetings and training. +… more
- Actalent (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. * Key focus is on providing clinical trial management support to study teams and tracking CRO and ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within... system, Clinical project management, cro, irb, clinical study, regulatory documents, clinical trial… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …internally sourced studies and/or CRO/Partnered studies. Collaborates and interacts with clinical trial managers, development program managers, medical monitors, ... The **Sr Manager , Clinical Drug Supply & Logistics**...orders according to supply plans or as requested by Clinical Trial Management team, to ensure timely… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The **Assoc Manager Clinical Study** (CSAM) role supports the Clinical Study Lead (CSL) by taking responsibility for areas of clinical trial delivery ... maintenance of study systems including but not limited to Clinical Trial Management System (CTMS) and ...including but not limited to database lock, reconciliation of vendor contract, study budget, TMF and study drug accountability… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within...other vendor performance against project goals and milestones to monitor… more
- Pfizer (New York, NY)
- …* Experience in understanding of key drivers impacting budgets and experience building a Clinical Trial Budget and managing project to budget Skills: * Strategic ... JOB SUMMARY . * Clinical Development expert focused on the execution of...the approved budget and with quality. * Experienced project manager and matrix leader accountable for leading the study… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ Excellent time management skills preferred. + Experience with PH.1 - PH. IV clinical trial vendor contracts required. + Experience with CRO contracts ... preferably in Life Sciences required Experience Qualifications + 4 or More Years in clinical trial outsourcing, health sciences or related field ( clinical … more
